Age Related Macular Degeneration (ARMD)NCT07514559
Comparison of Intravitreal Anti-VEGF Treatment Burden in Different Retinal Diseases
An observational study of Age Related Macular Degeneration (ARMD) and Retinal Vein Occlusion (RVO), run by Hospital Hietzing at 1 site in Austria.
Trial summary
The study compares the perceived treatment burden in patients undergoing intravitreal anti-VEGF treatment for either wet age related macular degeneration, macular edema after retinal vein occlusions or diabetic macular edema. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Age Related Macular Degeneration (ARMD), Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME)
- How many people
- 393 participants
- Where
- 1 siteAustria
- Study dates
- 1 May 2023to 30 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 393 patients (305 with nAMD, 55 with CME and 33 with DME)
Who may be able to join
- undergone a minimum of 5 IVT's and had visited the retina clinic for at least 6 months
Who cannot join
- eye surgery in the preceding six months
- notable cognitive impairment, such as dementia
- age <18 years
Trial locations and contacts
1 site in 1 country.
About this study
The study compares the perceived treatment burden in patients undergoing intravitreal anti-VEGF treatment for either wet age related macular degeneration, macular edema after retinal vein occlusions or diabetic macular edema. This study is the first to the investigator's knowledge to compare treatment burden between all three patient groups, which also differ in age and socioeconomic circumstances. The results are of interest to all ophthalmologists who prescribe anti-VEGF treatments, as they show factors which can influence patient adherence und thus the efficacy of said therapies.
- Conditions
- Age Related Macular Degeneration (ARMD), Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME)
- Keywords
- Treatment burden, ARMD, RVO, DME, anti-VEGF
- Medical subject headings
- Macular Degeneration, Retinal Vein Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| AMD | Patients with AMD receiving anti-VEGF treatment | |
| DME | Patients with DME receiving anti-VEGF treatment | |
| RVO | Patients with RVO receiving anti-VEGF treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severitiy of subjective treatment burden due to intravitreal anti-VEGF therapy assessed by questionnaire
The questionnaire was designed on the basis of the Longitudinal assessment of Adherence Factors to Intravitreal (anti-VEGF) Therapy (LAF-IVT) questionnaire. Patients were interviewed about their perceived treatment burden, their socioeconomic status, and demographic details. Different aspects of treatment burden were graden by the patients as "no", "little", "moderate", "great" or "extreme buden".
Measured: From May 2023 to April 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start1 May 2023
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age Related Macular Degeneration (ARMD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 393 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Hietzing
- Sponsor type
- University, hospital or other
- Collaborators
- Scientific fund of the City of Vienna
- Responsible party
- Principal investigator, Prof. Dr. Pia Vécsei-Marlovits, Hospital Hietzing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07514559
- Sponsor's protocol ID
- EK 22-198-VK
- Status last verified
- Apr 2026
- First submitted
- 26 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intravitreal Anti-VEGF Treatment Burden in Different Retinal Diseases
- ClinicalTrials.gov ID
- NCT07514559
- Acronym / sponsor ID
- EK 22-198-VK
- Conditions
- Age Related Macular Degeneration (ARMD), Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME)
- Keywords
- Treatment burden, ARMD, RVO, DME, anti-VEGF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 393 participants (actual)
- Lead sponsor
- Hospital HietzingUniversity, hospital or other
- Collaborators
- Scientific fund of the City of Vienna
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study compares the perceived treatment burden in patients undergoing intravitreal anti-VEGF treatment for either wet age related macular degeneration, macular edema after retinal vein occlusions or diabetic macular edema. This study is the first to the investigator's knowledge to compare treatment burden between all three patient groups, which also differ in age and socioeconomic circumstances. The results are of interest to all ophthalmologists who prescribe anti-VEGF treatments, as they show factors which can influence patient adherence und thus the efficacy of said therapies.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AMD | – | –Patients with AMD receiving anti-VEGF treatment |
| DME | – | –Patients with DME receiving anti-VEGF treatment |
| RVO | – | –Patients with RVO receiving anti-VEGF treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 393 patients (305 with nAMD, 55 with CME and 33 with DME)
Key inclusion criteria (1 listed)
- undergone a minimum of 5 IVT's and had visited the retina clinic for at least 6 months
Key exclusion criteria (3 listed)
- eye surgery in the preceding six months
- notable cognitive impairment, such as dementia
- age <18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Severitiy of subjective treatment burden due to intravitreal anti-VEGF therapy assessed by questionnaire
Time frame: From May 2023 to April 2024
The questionnaire was designed on the basis of the Longitudinal assessment of Adherence Factors to Intravitreal (anti-VEGF) Therapy (LAF-IVT) questionnaire. Patients were interviewed about their perceived treatment burden, their socioeconomic status, and demographic details. Different aspects of treatment burden were graden by the patients as "no", "little", "moderate", "great" or "extreme buden".
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Age Related Macular Degeneration (ARMD) and Retinal Vein Occlusion (RVO), run by Hospital Hietzing at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severitiy of subjective treatment burden due to intravitreal anti-VEGF therapy assessed by questionnaire (time frame: From May 2023 to April 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.